Catalog Number

C7601

Brand Name

CUSA® Clarity

Version/Model Number

C7601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LBK

Product Code Name

Device, neurosurgical fragmentation and aspiration

Public Device Record Key

9a12475f-d4c0-4074-b33b-c6084253b9dc

Public Version Date

October 26, 2022

Public Version Number

3

DI Record Publish Date

January 16, 2019

Package DI Number

30381780466240

Quantity per Package

5

Contains DI Package

10381780466246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box